US11529258B2 - Adjustable flow glaucoma shunts and associated systems and methods - Google Patents

Adjustable flow glaucoma shunts and associated systems and methods Download PDF

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US11529258B2
US11529258B2 US17/606,661 US202117606661A US11529258B2 US 11529258 B2 US11529258 B2 US 11529258B2 US 202117606661 A US202117606661 A US 202117606661A US 11529258 B2 US11529258 B2 US 11529258B2
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flow control
drainage
relative
control element
port
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US20220142818A1 (en
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Robert Chang
Katherine Sapozhnikov
Claudio Argento
Tom Saul
Richard Lilly
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Shifamed Holdings LLC
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Shifamed Holdings LLC
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Assigned to SHIFAMED HOLDINGS, LLC reassignment SHIFAMED HOLDINGS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LILLY, RICHARD, ARGENTO, CLAUDIO, CHANG, ROBERT, SAPOZHNIKOV, Katherine, SAUL, TOM
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the present technology generally relates to implantable medical devices and, in particular, to intraocular shunting systems and associated methods for selectively controlling fluid flow between different portions of a patient's eye.
  • Glaucoma is a degenerative ocular condition involving damage to the optic nerve that can cause progressive and irreversible vision loss. Glaucoma is frequently associated with ocular hypertension, an increase in pressure within the eye, and may result from an increase in production of aqueous humor (“aqueous”) within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. Aqueous is produced in the ciliary body at the boundary of the posterior and anterior chambers of the eye. It flows into the anterior chamber and eventually into the venous vessels of the eye. Glaucoma is typically caused by a failure in mechanisms that transport aqueous out of the eye and into the blood stream.
  • aqueous humor aqueous humor
  • FIG. 1 A is a simplified front view of an eye E with an implanted shunt
  • FIG. 1 B is an isometric view of the eye capsule of FIG. 1 A .
  • FIGS. 2 A- 2 C illustrate an adjustable shunt configured in accordance with embodiments of the present technology.
  • FIG. 3 A illustrates select features of the shunt shown in FIGS. 2 A- 2 C configured in accordance with embodiments of the present technology.
  • FIG. 3 B illustrates select features of the shunt shown in FIGS. 2 A- 2 C configured in accordance with embodiments of the present technology.
  • FIGS. 4 A and 4 B illustrate a drainage plate for use with an adjustable shunt configured in accordance with select embodiments of the present technology.
  • FIG. 4 C is a schematic illustration of an electrical circuit having parallel resistors.
  • FIGS. 5 A and 5 B illustrate a drainage plate for use with an adjustable shunt configured in accordance with select embodiments of the present technology.
  • FIG. 5 C is a schematic illustration of an electrical circuit having serial resistors.
  • FIG. 6 illustrates a shunt configured in accordance with select embodiments of the present technology.
  • the present technology is directed to systems, devices, and methods for treating glaucoma.
  • some embodiments provide shunts having a plurality of individually actuatable flow control elements that can control the flow of fluid through associated ports and/or channels in the shunt.
  • each individually actuatable flow control element can be actuated to substantially block and/or substantially unblock a corresponding port and/or channel, thereby inhibiting or permitting flow through the port and/or channel.
  • the shunts described herein can be manipulated into a variety of configurations that provide different drainage rates based on whether the ports and/or channels are blocked or unblocked, therefore providing a titratable glaucoma therapy for draining aqueous from the anterior chamber of the eye.
  • the flow control elements can be non-invasively adjusted after the shunt is implanted in the eye to allow for post-implant adjustments.
  • the shunting systems include ports and/or drainage channels that are configured to provide a different therapy level relative to other ports and/or drainage channels of the system.
  • a first port and/or channel may be associated with a first drainage rate and/or first fluid resistance
  • a second port and/or channel may be associated with a second drainage rate and/or second fluid resistance
  • a third port and/or channel may be associated with a third drainage rate and/or third fluid resistance.
  • this can be accomplished by having ports and/or drainage channels having different dimensions (e.g., diameters, cross-section areas, lengths, etc.).
  • the ports and channels are arranged as parallel fluid resistors relative to a primary drainage lumen.
  • the inflow ports and channels are arranged as serial fluid resistors relative to the primary drainage lumen.
  • each individual port may be associated with a discrete and different relative resistance and/or flow.
  • a first port may enable a flow of 1X
  • a second port may enable a flow of 2X
  • a third port may enable a flow of 3X.
  • any combination of ports can be opened (e.g., unblocked) or closed (e.g., blocked, interfered with, etc.) to provide additional discrete relative resistances and/or drainage rates that differ from the discrete relative resistances and flows associated with each individual port.
  • both the second and third ports can be opened to provide a flow of 5X.
  • the relative dimensions of the ports and/or channels can be selected to specifically provide the greatest number of discrete therapy levels.
  • a ratio between the first drainage rate, second drainage rate, and third drainage rate can be about 1:2:4.
  • a ratio between the first resistance, the second resistance, and the third resistance can be about 4:2:1. Without being bound theory, this is expected to increase the number of discrete therapy levels the systems can provide, which in turn is expected to enable a healthcare to specifically tailor the therapy level to a particular patient's needs.
  • each individual inflow port may still be associated with a discrete resistance and/or drainage rate.
  • the systems cannot be manipulated to achieve a plurality of combined resistances and/or flow rates different than the discrete resistances and/or drainage rates provided by each individual port.
  • any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions.
  • the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like.
  • heart failure e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.
  • pulmonary failure pulmonary failure
  • renal failure e.g., pulmonary failure, renal failure, hydrocephalus, and the like.
  • the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
  • Glaucoma refers to a group of eye diseases associated with damage to the optic nerve which eventually results in vision loss and blindness.
  • glaucoma is a degenerative ocular condition characterized by an increase in pressure within the eye resulting from an increase in production of aqueous within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. The increased pressure leads to injury of the optic nerve over time.
  • patients often do not present with symptoms of increased intraocular pressure until the onset of glaucoma. As such, patients typically must be closely monitored once increased pressure is identified even if they are not symptomatic. The monitoring continues over the course of the disease so clinicians can intervene early to stem progression of the disease.
  • Surgical or minimally invasive approaches primarily attempt to increase the outflow of aqueous from the anterior chamber to the blood stream either by the creation of alternative fluid paths or the augmentation of the natural paths for aqueous outflow.
  • FIGS. 1 A and 1 B illustrate a human eye E and suitable location(s) in which a shunt may be implanted within the eye E in accordance with embodiments of the present technology. More specifically, FIG. 1 A is a simplified front view of the eye E with an implanted shunt 100 , and FIG. 1 B is an isometric view of the eye E and the shunt 100 of FIG. 1 A .
  • the eye E includes a number of muscles to control its movement, including a superior rectus SR, inferior rectus IR, lateral rectus LR, medial rectus MR, superior oblique SO, and inferior oblique IO.
  • the eye E also includes an iris, pupil, and limbus.
  • the shunt 100 can have a drainage element 105 (e.g., a drainage tube) positioned such that an inflow portion 101 is positioned in an anterior chamber of the eye E, and an outflow portion 102 is positioned at a different location within the eye E, such as a bleb space.
  • the shunt 100 can be implanted in a variety of orientations.
  • the drainage element 105 may extend in a superior, inferior, medial, and/or lateral direction from the anterior chamber.
  • the outflow portion 102 can be placed in a number of different suitable outflow locations (e.g., between the choroid and the sclera, between the conjunctiva and the sclera, etc.).
  • Outflow resistance can change over time for a variety of reasons, e.g., as the outflow location goes through its healing process after surgical implantation of a shunt (e.g., shunt 100 ) or further blockage in the drainage network from the anterior chamber through the trabecular meshwork, Schlemm's canal, the collector channels, and eventually into the vein and the body's circulatory system.
  • a clinician may desire to modify the shunt after implantation to either increase or decrease the outflow resistance in response to such changes or for other clinical reasons. For example, in many procedures the shunt is modified at implantation to temporarily increase its outflow resistance.
  • the modification to the shunt is reversed, thereby decreasing the outflow resistance.
  • the clinician may implant the shunt and after subsequent monitoring of intraocular pressure determine a modification of the drainage rate through the shunt is desired.
  • Such modifications can be invasive, time-consuming, and/or expensive for patients. If such a procedure is not followed, however, there is a high likelihood of creating hypotony (excessively low eye pressure), which can result in further complications, including damage to the optic nerve.
  • intraocular shunting systems configured in accordance with embodiments of the present technology allow the clinician to selectively adjust the flow of fluid through the shunt after implantation without additional invasive surgical procedures.
  • the shunts described herein can be implanted having a first drainage rate and subsequently remotely adjusted to achieve a second, different drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt may be implanted at a first lower flow rate and subsequently adjusted to a second higher flow rate as clinically necessary.
  • the shunts described herein can be delivered using either ab interno or ab externo implant techniques, and can be delivered via needles.
  • the needles can have a variety of shapes and configurations to accommodate the various shapes of the shunts described herein. Details of the implant procedure, the implant devices, and bleb formation are described in greater detail in International Patent Application No.
  • the flow control assemblies are configured to introduce features that selectively impede or attenuate fluid flow through the shunt during operation. In this way, the flow control assemblies can incrementally or continuously change the flow resistance through the shunt to selectively regulate pressure and/or flow.
  • the flow control assemblies configured in accordance with the present technology can accordingly adjust the level of interference or compression between a number of different positions, and accommodate a multitude of variables (e.g., TOP, aqueous production rate, native aqueous outflow resistance, and/or native aqueous outflow rate) to precisely regulate flow rate through the shunt.
  • the disclosed flow control assemblies can be operated using energy. This feature allows such devices to be implanted in the patient and then modified/adjusted over time without further invasive surgeries or procedures for the patient. Further, because the devices disclosed herein may be actuated via energy from an external energy source (e.g., a laser), such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators/fluid resistors disclosed herein can maintain a desired position/orientation without power. This can significantly increase the usable lifetime of such devices and enable such devices to be effective long after the initial implantation procedure.
  • an external energy source e.g., a laser
  • FIGS. 2 A- 2 C illustrate an adjustable shunt 200 (“shunt 200 ”) configured in accordance with embodiments of the present technology.
  • the shunt 200 includes a drainage element or tube 202 having a first end portion 204 and a second end portion 206 opposite the first end portion 204 .
  • the drainage element 202 can have a plurality of inflow ports or apertures (referred to herein as ports 208 —shown in FIG. 2 B ) at or adjacent to the first end portion 204 and an outflow aperture 207 at or adjacent the second end portion 206 .
  • the ports 208 can be arranged and/or configured such that they provide the equivalent of a set of parallel fluid resistors accessing a primary lumen of the device.
  • the primary lumen can extend through the drainage element 202 to fluidly connect the plurality of ports 208 and the outflow aperture 207 .
  • the shunt 200 can also be referred to as a parallel resistor.
  • the drainage element 202 can be relatively flat such that its height is less than its width (e.g., the drainage element 202 has an oval, rectangular, or “D-shaped” cross sectional shape).
  • the drainage element 202 may have an outer diameter (e.g., height) of about 1000 microns ( ⁇ m) or less, about 400 ⁇ m or less, or about 300 ⁇ m or less.
  • the drainage element 202 can have an outer diameter value that is between any of the aforementioned values of outer diameter.
  • the drainage element may have an inner diameter of about 800 ⁇ m or less, about 300 ⁇ m or less, or about 200 ⁇ m or less.
  • the drainage element 202 can have an inner diameter value that is between any of the aforementioned values of inner diameter.
  • the drainage element 202 can have a length that is about 2 mm, about 2.5 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 15 mm, or about 20 mm.
  • the drainage element 202 can have a length that is between any of the aforementioned values of length.
  • the drainage element 202 can be substantially cylindrical. Without wishing to be bound by theory, having a relatively flat profile is expected to advantageously reduce interference with native tissue while providing increased stability of the shunt 200 .
  • the shunt 200 can include a flow control mechanism 210 positioned at the first end portion 204 of the drainage element 202 .
  • the first end portion 204 can reside within an anterior chamber and the second end portion 206 can reside in a desired outflow location (e.g., a bleb space, such as those described in International Patent Application No. PCT/US20/41152, previously incorporated by reference herein).
  • the flow control mechanism 210 is located within the anterior chamber.
  • the first end portion 204 can reside within the desired outflow location and the second end portion 206 can reside within the anterior chamber (e.g., fluid would flow from the outflow aperture 207 to the ports 208 ).
  • the flow control mechanism 210 is positioned outside of the anterior chamber (e.g., in the bleb space). Regardless of the orientation of the shunt 200 , the shunt 200 is configured to drain aqueous from the anterior chamber when the shunt 200 is implanted in the eye.
  • the shunt 200 may optionally have additional features that help secure the shunt 200 in place when implanted in the eye.
  • the shunt 200 can include arms, anchors, plates, or other suitable features (not shown) that can secure the shunt 200 to native tissue.
  • the shunt 200 may also include an outer membrane or cover (e.g., a transparent and/or biocompatible membrane) that encases some or all of the shunt 200 .
  • the flow control mechanism 210 includes a plurality of flow control elements 211 a - d arranged along the length of the drainage element 202 .
  • Individual flow control elements 211 a - d can interface with a corresponding individual port 208 , and each flow control element 211 a - d can be individually actuatable.
  • the shunt 200 can be manipulated into any number of configurations with all ( FIG. 2 C ), some, or none ( FIG. 2 B ) of the ports 208 blocked or substantially blocked. The more ports 208 that are unblocked or otherwise accessible, the more fluid is able to drain via the drainage element 202 . As described in detail with respect to FIGS.
  • the ports 208 can have the same or different dimensions.
  • the ports 208 are generally regularly spaced apart (e.g., spaced about 1 mm apart).
  • the ports 208 are spaced to have varied distances between adjacent ports 208 .
  • at least two adjacent ports 208 can have a spacing distance that is different than a spacing distance between other ports 208 of the plurality of ports 208 .
  • Each flow control element 211 a - d includes a pair of anchors 212 (e.g., the first flow control element 211 a includes a first anchor 212 a and second anchor 212 b ) spaced apart along a length of the drainage element 202 .
  • adjacent flow control elements 211 a - d may share an anchor.
  • the second anchor 212 b anchors both the first flow control element 211 a and the second flow control element 211 b .
  • the anchors 212 are secured to the drainage element 202 such that at least one of the ports 208 is positioned generally between each pair of anchors.
  • the anchors 212 can be secured to the drainage element 202 or other structure such that they do not move when the flow control elements 211 a - d are actuated.
  • the anchors 212 may wrap around a circumference of the drainage element 202 and be secured thereto via a friction fit or other suitable attachment mechanism.
  • the anchors 212 do not wrap around the full circumference of the drainage element but nevertheless secure the flow control mechanism 210 to the drainage element 202 (e.g., via welding, gluing, or other suitable adhesion techniques).
  • Each individual flow control element 211 a - d further includes a moveable gating element (e.g., flow control element 211 a includes a gating element 216 a , flow control element 211 b includes a gating element 216 b , etc., collectively referred to herein as gating element 216 ), a first actuation element (e.g., flow control element 211 a includes a first actuation element 214 a ) extending between a first anchor (e.g., the first anchor 212 a ) and the corresponding gating element 216 (e.g., gating element 216 a ), and a second actuation element (e.g., flow control element 211 b includes a second actuation element 214 b ) extending between a second anchor (e.g., the second anchor 212 b ) and the corresponding gating element 216 .
  • a moveable gating element e.g.
  • Each gating element 216 a - d is configured to interface with (e.g., at least partially block or otherwise form a substantial or full fluid seal with) a corresponding port 208 .
  • the actuation elements can be selectively activated to selectively move the corresponding gating element 216 between one or more positions blocking (or partially blocking) the corresponding port 208 and one or more positions unblocking (or at partially unblocking) the corresponding port 208 .
  • the gating element 216 a of the first flow control element 211 a can be moved between a first open position permitting fluid to flow into the drainage element 202 via the corresponding port 208 and a first closed position substantially preventing fluid from flowing into the drainage element 202 via the corresponding port 208
  • the gating element 216 b of the second flow control element 211 b can be moved between a second open position permitting fluid to flow into the drainage element 202 via the corresponding port 208 , and a second closed position substantially preventing fluid from flowing into the drainage element 202 via the corresponding port 208
  • the gating element 216 c of the third flow control element 211 c can be moved between a third open position permitting fluid to flow into the drainage element 202 via the corresponding port 208 , and a third closed position substantially preventing fluid from flowing into the drainage element 202 via the corresponding port 208
  • the gating element can also be described as not interfering with and/or imparting a first fluid resistance through the outlet when in the open position and interfering with and/or imparting a second fluid resistance greater than the first fluid resistance when in the closed position.
  • the gating elements 216 can be moved by actuating the actuation elements 214 .
  • actuating the second actuation element 214 a can move the gating element 216 a in a first direction
  • actuating the first actuation element 114 b can move the gating element 216 a in a second direction generally opposite the first direction.
  • the actuation elements can be composed at least partially of a shape memory material (e.g., a shape memory alloy) or other suitable material that is configured to change shape upon application of energy.
  • the actuation elements are composed of nitinol.
  • the actuation elements can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.).
  • a first material phase or state e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.
  • a second material phase or state e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.
  • the actuation element or select region thereof may be deformable (e.g., plastic, malleable, compressible, expandable, etc.).
  • the actuation element or select region thereof may have a preference toward a specific preferred geometry (e.g., original geometry, manufactured or fabricated geometry, heat set geometry, etc.).
  • the actuation elements can be individually and/or selectively transitioned between the first material state and the second material state by applying energy (e.g., heat, light, etc.) to the actuation element to heat the actuation element above a transition temperature (e.g., a phase transition temperature). If the actuation element is deformed relative to its preferred geometry, the transition from the first material state to the second material state can induce a dimensional change in the actuation element. In some embodiments, the dimensional change is an expansion.
  • the dimensional change is a contraction (e.g., compression).
  • the energy is applied from an energy source positioned external to the eye (e.g., a laser), which can enable a user to non-invasively adjust the shunt.
  • the flow control element 211 a (e.g., the first actuation element 214 a or the second actuation element 214 b ) can be actuated to move (e.g., translate) the gating element 216 a along the axial length of the drainage element 202 between the first anchor 212 a and the second anchor 212 b .
  • This movement of the gating element 216 a can cause it to block (e.g., partially or fully block) and/or unblock (e.g., partially or fully unblock) the associated port 208 .
  • first actuation element 214 a is compressed relative to its preferred geometry
  • heating the first actuation element 214 a above its transition temperature can cause the first actuation element 214 a to expand and/or stiffen (thereby expanding in length).
  • the first anchor 212 a and the second anchor 212 b are secured in place (e.g., they do not move relative to the drainage element 202 )
  • the first actuation element 214 a pushes the gating element 216 a away from the first anchor 212 a as it expands (and toward the second anchor 212 b ).
  • heating the second actuation element 214 b causes the second actuation element 214 b to expand, which pushes the gating element 216 a away from the second anchor 212 b and back towards the first anchor 212 a .
  • this can cause the gating element 216 a to block the port 208 , thereby preventing flow into (or out of) the port 208 .
  • first actuation element 214 a and/or the second actuation element 214 b can be selectively targeted to block and/or unblock the port 208 .
  • first actuation element 214 a and/or the second actuation element 214 b can be actuated to partially block or partially unblock the port 208 , rather than completely blocking and/or unblocking the port 208 .
  • the actuation elements are configured to retain or substantially retain their shape following application of energy. For example, if energy is applied to the first actuation element 214 a to transition the first flow control element 211 a from the configuration shown in FIG. 2 C to the configuration shown in FIG. 2 B , the first flow control element 211 a can retain the configuration shown in FIG. 2 B until further energy is applied to the first flow control element 211 a . Accordingly, once the first flow control element 211 a is actuated to unblock the corresponding port 208 , the corresponding port 208 remains unblocked until further energy is applied to the first flow control element 211 a (e.g., by application of energy to the second actuation element 214 b ). In other embodiments, the actuation elements may exhibit a (e.g., partial) recoil effect, in which the energized actuation element recoils towards an original shape once the application of energy is terminated.
  • the shunt 200 can be set such that, at body temperature, all, some, or none of the ports 208 are blocked by the corresponding gating elements 216 . Accordingly, in some embodiments the shunt 200 can have a base configuration in which all, some, or none of the ports 208 are blocked by the corresponding gating elements 216 .
  • the drainage of aqueous through the shunt 200 can be selectively controlled by selectively blocking and/or unblocking the ports 208 using the flow control elements 211 a - d .
  • the flow control elements 211 a - d can be actuated such that any combination of ports 208 are blocked or unblocked to provide multiple different therapy levels.
  • each port 208 may be configured to provide a different level of therapy (e.g., resistance) relative to each other when the shunt 200 is exposed to a given pressure.
  • FIG. 3 A illustrates an embodiment of the shunt 200 having four ports 208 a - d (e.g., apertures), with each port 208 a - d having different dimensions.
  • each of the ports 208 a - d can have a different diameter that corresponds to a different relative flow rate and/or resistance.
  • the port 208 a has a first diameter
  • the port 208 b has a second diameter greater than the first diameter
  • the port 208 c has a third diameter greater than the second diameter
  • the port 208 d has a fourth diameter greater than the third diameter.
  • the diameter of the ports 208 a - d can range between about 4 microns to about 16 microns, from between about 8 microns to about 22 microns, from between about 15 microns to about 60 microns, or from between about 25 microns to about 100 microns, although in other embodiments the diameters of some or all of the ports 208 a - d may fall outside the foregoing ranges.
  • Each of the ports 208 a - d can correspond to an individual flow control element 211 a - d (omitted in FIG. 3 A for clarity). Accordingly, each of the ports 208 a - d can be selectively blocked or unblocked by actuating the corresponding flow control element 211 a - d , as described above with respect to FIGS. 2 A- 2 C .
  • the flow control elements 211 a - d can be actuated such that one or more of the port(s) 208 a - d (i) have a first fluid flow cross-section providing a first level of therapy (e.g., when the ports 208 a - d are completely open and accessible), or (ii) have a second fluid flow cross-section providing a second level of therapy less than the first level of therapy (e.g., when the port(s) 208 a - d are at least partially covered by the corresponding flow control elements 211 a - d ).
  • any combination of ports 208 a - d can be blocked and any combination of ports 208 a - d can be unblocked based on the positioning of the corresponding flow control element 211 a - d.
  • Each of the ports 208 a - d can be associated with a desired fluid flow and/or drainage rate relative to other ports 208 a - c (e.g., when operating under a given pressure).
  • the relative drainage rates provided through each individual port 208 a - d increases by a common value from the port 208 a to the port 208 d under a given pressure.
  • the port 208 a may be associated with a relative drainage rate of about X
  • the port 208 b may be associated with a relative drainage rate of about 2X
  • the port 208 c may be associated with a relative drainage rate of about 3X
  • the port 208 d may be associated with a relative drainage rate of about 4X.
  • the ratio of relative flow rates for the ports 208 a - d is 1:2:3:4.
  • the flow control elements 211 a - d can be manipulated to achieve any drainage rate between about X (only the port 208 a is unblocked) and about 10X (all of the ports 208 a - d are unblocked).
  • the corresponding flow control elements can be manipulated to achieve any drainage rate between about X (only the port 208 a is unblocked) and about 6X (all of the ports 208 a - c are unblocked).
  • Table 1 below reflects the relative drainage rate (flow) and associated resistance values for embodiments in which a ratio of the relative flow rates for the ports 208 a - d is 1:2:3:4.
  • the relative drainage rates through the respective ports 208 a - d do not increase by a common value from the port 208 a to the port 208 d , but rather are selectively sized to achieve a greater number of discrete possible drainage rates (e.g., to avoid overlapping values).
  • the port 208 a may be associated with a relative drainage rate of about X
  • the port 208 b may be associated with a relative drainage rate of about 2X
  • the port 208 c may be associated with a relative drainage rate of about 4X.
  • the ratios of relative flow rates for the ports 208 a - c is 1:2:4.
  • the ports 208 a - c can be selectively blocked and unblocked by the corresponding flow control elements 311 a - c to achieve a variety of desired drainage rates. For example, if only the port 208 a is unblocked, the drainage rate is about X, if only the port 208 b is unblocked, the drainage rate is about 2X, if both the port 208 a and 208 b are unblocked, the drainage rate is about 3X, if only the port 208 c is unblocked, the drainage rate is about 4X, if the port 208 a and 208 c are unblocked, the drainage rate is about 5X, if the port 208 b and 208 c are unblocked, the drainage rate is about 6X, and if ports 208 a , 208 b , and 208 c are all unblocked, the drainage rate is about 7X.
  • a shunt with three ports having a relative drainage ratio of 1:2:3 can provide six discrete potential drainage rates
  • a shunt with three ports with a relative drainage ratio of 1:2:4 can provide at least seven different potential drainage rates. Accordingly, by varying the dimensions of the ports 208 as described above, a greater number of relative drainage rates can be accomplished with fewer number of ports 208 . In embodiments having four ports 208 , the port 208 d can have a relative drainage rate of about 8X to further increase the number of unique drainage rates possible (e.g., the ratio of relative flow rates for the ports 208 a - d is 1:2:4:8).
  • a user can therefore select which ports 208 are blocked and which ports 208 are unblocked to achieve any of the desired drainage rates.
  • Table 2 below reflects the relative drainage rate (flow) and associated resistance values for embodiments in which a ratio of the relative flow rates for the ports 208 a - d is 1:2:4:8.
  • the ratios of relative flow rates for the ports 208 a - c can be values other than 1:2:4:8 or 1:2:3:4.
  • the ratio can be 1:1:1:1, 1:1:2:2, 1:1:1:2, etc.
  • the ratio may be random (e.g., 1:6:2:3, 4:2:5:1, etc.).
  • the foregoing flow characteristics can also be described in terms of the resistances provided by each individual port 208 a - d .
  • the port 208 a when unblocked or otherwise accessible, can have a first resistance, the port 208 b can have a second resistance less than the first resistance, the port 208 c can have a third resistance less than the second resistance, and the port 208 d can have a fourth resistance less than the third resistance.
  • the resistances can have a predetermined ratio. In some embodiments, for example, the ratio of the resistance provided port 208 a to the port 208 b to the port 208 c to the port 208 d can be 4:3:2:1, 8:4:2:1, 1:1:1:1, or other ratios.
  • Table 3 below reflects the relative resistance and associated flow for embodiments in which a ratio of the relative resistances for the ports 208 a - d is 4:3:2:1.
  • Table 4 below reflects the relative resistance and associated flow for embodiments in which a ratio of the relative resistances for the ports 208 a - d is 1:2:4:8.
  • the shunt 200 and other shunts described herein can have two, three, four, five, six, seven, eight, or more ports 208 , each with a corresponding flow control element 211 .
  • Increasing the number of ports 208 generally increases the number of different drainage rates that can be implemented because as the number of ports 208 increases, the number of unique combinations of blocked and/unblocked ports increases as well.
  • the ports 208 can also be selectively sized to provide the greatest number of potential therapy levels.
  • the ratio of the relative flow rates for the ports can be about 1:2 and/or the ratio of the relative resistances for the ports can be about 2:1 (e.g., producing a total of four discrete therapy levels). In other embodiments with two ports, the ratio of the relative flow rates is about 1:1 and/or the ratio of the relative resistances is about 1:1. In embodiments with three ports, the ratio of the relative flow rates for the ports can be about 1:2:4 and/or the ratio of the relative resistances for the ports can be about 4:2:1 (e.g., producing a total of eight discrete therapy levels).
  • the ratio of the relative flow rates is about 1:1:1 or about 1:2:3, and/or the ratio of the relative resistances is about 1:1:1 or about 3:2:1.
  • the ratio of the relative flow rates for the ports can be about 1:2:4:8 and/or the ratio of the relative resistances for the ports can be about 8:4:2:1 (producing a total of sixteen discrete therapy levels).
  • the ratio of the relative flow rates is about 1:1:1:1 or about 1:2:3:4, and/or the ratio of the relative resistances is about 1:1:1:1 or about 4:3:2:1.
  • the ratio of the relative flow rates for the ports can be about 1:2:4:8:16 and/or the ratio of the relative resistances for the ports can be about 16:8:4:2:1 (producing a total of thirty-two discrete therapy levels). In other embodiments with five ports, the ratio of the relative flow rates is about 1:1:1:1:1 or about 1:2:3:4:5, and/or the ratio of the relative resistances is about 1:1:1:1:1 or about 5:4:3:2:1.
  • FIG. 3 B illustrates another embodiment of the shunt 200 in which the number of ports 208 (e.g., apertures) corresponding to each flow control element 211 a - d varies but a dimension of each port 208 is the same or at least generally the same.
  • the drainage element 202 can have one port 208 corresponding to the first flow control element 211 a , two ports 208 corresponding to the second flow control element 211 b , four ports 208 corresponding to the third flow control element 211 c , and eight ports 208 corresponding to the fourth flow control element 211 d .
  • the ports 208 corresponding to the first flow control element 211 a can provide a relative drainage rate of X
  • the ports 208 corresponding to the second flow control element 211 b can provide a relative drainage rate of about 2X
  • the ports 208 corresponding to the third flow control element 211 c can provide a relative drainage rate of about 4X
  • the ports 208 corresponding to the flow control element 211 d can provide a relative drainage rate of about 8X (e.g., the ratio of the relative flow rates between ports 208 remain 1:2:4:8).
  • each of the flow control elements 211 a - d can be individually actuated to block and/unblock the corresponding ports 208 .
  • providing ports that facilitate the foregoing drainage rates increases the number of possible drainage rates while decreasing the number of flow control elements needed.
  • the number of ports 208 corresponding to each flow control elements 211 a - d increases by one.
  • the ports 208 do not have the same dimensions.
  • the shunt 200 may include a plurality of discrete and fluidly isolated lumens or channels associated with individual ports 208 .
  • the therapy level e.g., drainage rate, resistance, etc.
  • the shunt 200 can still include different size ports 208 ( FIG. 3 A ) or different numbers of ports 208 ( FIG.
  • one aperture means the corresponding lumen has a first resistance
  • two apertures means the corresponding lumen has a second resistance less than the first resistance
  • the gating elements 216 can be manipulated such that the ports 208 a - d occupy one or more positions between fully open or fully closed. This can further increase the number of discrete therapy levels that the shunt 200 can provide. In yet other embodiments, the gating elements 216 may permit some fluid to leak through the ports 208 a - d even in the closed positions (e.g., the gating elements 216 do not form a perfect fluid seal with the ports 208 a - d when in the closed position).
  • FIGS. 4 A and 4 B illustrate select features of a shunt 400 having a drainage plate 440 configured in accordance with select embodiments of the present technology. More specifically, FIG. 4 A is a partially isometric view of the plate 440 and FIG. 4 B is a partially schematic top down view of the plate 440 .
  • the plate 440 includes a plurality of inflow ports 408 that permit fluid to flow into a plurality of corresponding channels 422 .
  • the channels 422 empty into a lumen 405 via a plurality of outflow ports 409 .
  • the plurality of inflow ports 408 and/or channels 422 are arranged as parallel fluid resistors, and can therefore exhibit similar flow characteristics as those described above with respect to the shunt 200 ( FIGS. 2 A- 3 B ).
  • the lumen 405 can direct fluid toward a desired outflow location (e.g., a bleb space) and/or an elongated drainage element (not shown).
  • the shunt 400 can include a flow control mechanism (not shown) operably coupled to the drainage plate 440 to control the flow of fluid through the channels 422 .
  • the flow control mechanism includes a plurality of individually actuatable flow control elements associated with individual inflow ports 408 and channels 422 .
  • a flow control mechanism generally similar to the flow control mechanism 210 described with respect to FIGS. 2 A- 2 C can be disposed over the plate 440 such that flow control elements 211 a - d interface with the inflow ports 408 .
  • aspects of the flow control mechanism 210 may be slightly modified to account for the different structure of the shunt 400 .
  • the anchoring elements may not extend around the entirety of the shunt, but rather may be secured to an upper surface of the plate 440 (e.g., via welding, gluing or other suitable adhesives).
  • the flow control mechanism can be positioned such that individual flow control elements (e.g., flow control elements 211 a - d of FIGS. 2 A- 2 C ) are positioned to control the flow of fluid through individual ports 408 .
  • the flow control elements 211 a - d FIGS. 2 B and 2 C
  • other suitable flow control elements configured to at least partially block and/or unblock the flow of fluid through the channels 422 can be used.
  • the channels 422 may each have the same or about the same flow resistance.
  • opening additional channels 422 is expected to result in a stepwise increase in the drainage rate
  • blocking additional channels 422 is expected to result in a stepwise decrease in the drainage rate.
  • moving from a single open channel 422 to two open channels 422 is expected to generally double the drainage rate
  • moving from two open channels 422 to three open channels 422 is expected to generally increase the drainage rate by 50 percent.
  • the total number of unique resistances and thus flow rates that can be achieved is not maximized, since the resistance and flow when only a first lumen is unblocked is the same as the resistance and flow when only a second lumen in unblocked.
  • the channels 422 may have different resistances and thus different relative drainage rates.
  • each individual channel 422 may be associated with a desired drainage rate and/or resistance relative to one another.
  • a first channel may be associated with a drainage rate of about X
  • a second channel may be associated with a drainage rate of about 2X
  • a third channel may be associated with a drainage rate of about 4X, and so on.
  • a greater number of drainage rates can be accomplished with fewer channels 422 when each channel 422 is associated with a different drainage rate.
  • Flow resistance through the channels 422 can be varied based on, for example, a length of the channel and/or a diameter of the channel.
  • the length of the channel is generally proportional to the resistance of the channel, whereas the diameter of the channel is generally inversely proportional to the resistance of the channel.
  • each individual channel 422 may have a unique length, diameter, or length and diameter combination that gives it a certain resistance. Individual channels 422 can then be selectively opened (or closed) to achieve a desired flow rate.
  • FIG. 4 C is a schematic illustration of an electrical circuit 650 having a plurality of resistors R 1-4 in parallel.
  • Each resistor R 1-4 is analogous to an individual port or channel of a parallel resistor shunt (e.g., ports 208 a - d of the shunt 200 , ports 408 of the shunt 400 , or channels 422 of the shunt 400 ).
  • a plurality of switches S 1-4 can complete or break the circuit through each individual resistor R 1-4 .
  • each individual port being transitionable between an open (e.g., blocked) and closed (e.g., unblocked) state.
  • More than one switch S 1-4 being closed to complete the circuit 450 affects current flow through the circuit 450 in a similar manner as more than one port being open in a parallel resistor shunt.
  • the current could alternatively flow through the circuit 450 in a second direction opposite the first direction, similar to how the parallel resistor shunts described herein can operate with fluid flowing in either direction through the shunt.
  • FIGS. 5 A and 5 B illustrate features of a shunt 500 having a drainage plate 540 and configured to act as a serial fluid resistor. More specifically, FIG. 5 A is a top down partially isometric view of the drainage plate 540 , and FIG. 5 B is a bottom up partially isometric view of the drainage plate 540 . Unlike the drainage plate 440 ( FIG. 4 A ), the drainage plate 540 includes a single inflow port 508 allowing fluid to flow into a channel 522 .
  • the channel 522 includes a plurality of outflow ports 509 that allows fluid to flow out of the channel 522 and into a lumen (e.g., the lumen 405 described with respect to FIGS. 4 A and 4 B ) that directs fluid toward a desired outflow location (e.g., a bleb space) and/or an elongated drainage element (not shown).
  • the plurality of outflow ports 509 can be arranged in series along a length of the channel 522 , and/or can be fluidly coupled to the channel 522 by a plurality of conduits extending from the channel 522 .
  • the orientation of the drainage plate 540 can be reversed, such that fluid flows in the opposite direction (e.g., from the plurality of outflow ports 509 to the single inflow port 508 ).
  • the shunt 500 can include a flow control mechanism (not shown) operably coupled to the drainage plate 540 to control the flow of fluid out of the outflow ports 509 and into the lumen.
  • the flow control mechanism can include a plurality of individually actuatable flow control elements associated with individual outflow ports 509 .
  • a flow control mechanism generally similar to the flow control mechanism 210 ( FIGS. 2 A- 2 C ) described herein can be disposed on the plate 540 such that the flow control elements 211 a - d interface with the outflow ports 509 .
  • the plate 540 may be at least partially transmissive (e.g., transparent) to at least some forms of energy, such as laser energy having select wavelengths (e.g., between about 500 nm and about 600 nm, etc.).
  • other suitable flow control elements configured to at least partially block and/or unblock the flow of fluid through the outflow ports 509 can be used.
  • the plate 540 is configured to act as a serial resister.
  • the resistance is provided by the channel 522 (rather than the inflow port 508 and/or the outflow ports 509 ) and is based on the distance between the inflow port 508 and the closest open outflow port 509 .
  • the resistance to flow is the greatest (e.g., by virtue of the fluid having to travel the greatest distance through the channel 522 ).
  • the resistance is the least (e.g., by virtue of the fluid having to travel the shortest distance through the channel 522 ).
  • the channels/apertures behave as if they are in series, and thus the number of discrete resistances and drainage rates is generally equal to the number of outflow apertures 509 .
  • FIG. 5 C is a schematic illustration of an electrical circuit 550 having a four resistors R a-d in series.
  • Each resistor R a-d is analogous to an individual port of a serial resistor shunt (e.g., ports 509 of the shunt 500 ).
  • a plurality of switches Sa-d can complete or break the circuit. This is analogous to each individual port being transitionable between an open (e.g., blocked) and closed (e.g., unblocked) state.
  • More than one switch Sa-d being closed to complete the circuit 550 affects current flow through the circuit 550 in a similar manner as more than one port being open in a serial resistor shunt. Although shown as having a current flowing through the circuit 650 in a first direction, the current could alternatively flow through the circuit 650 in a second direction opposite the first direction, similar to how the serial resistor shunts described herein can operate with fluid flowing in either direction through the shunt.
  • FIG. 6 is an isometric view of a shunt 600 configured in accordance with select embodiments of the present technology.
  • the shunt 600 includes an elongated tube 602 having a first end portion 604 and a second end portion 606 .
  • the first end portion 604 is connected to a plate 640 .
  • the plate 640 can be generally similar to the plates 440 and/or 540 described above with respect to FIGS. 4 A and 4 B , and FIGS. 5 A and 5 B , respectively.
  • the first end portion 604 can be fluidly coupled to an interior of the plate 640 (e.g., the lumen 405 — FIG. 4 A ) and configured to receive fluid therefrom.
  • the second end portion 606 can include one or more ports (not shown).
  • the first end portion 604 and the plate 640 can reside within an anterior chamber and the second end portion 606 can reside in a desired outflow location (e.g., a bleb space). In other embodiments, the first end portion 604 and the plate 640 can reside within the desired outflow location and the second end portion 606 can reside within the anterior chamber. Regardless of the orientation of the shunt 600 , the shunt 600 is configured to drain aqueous from the anterior chamber when the shunt 600 is implanted in the eye. In some embodiments, the plate 640 may at least partially secure the shunt 600 in a desired position. The shunt 600 may optionally have additional features that help secure the shunt 600 in place when implanted in the eye. For example, the shunt 600 can include arms, anchors, plates, or other suitable features that secure the shunt 600 to native tissue.
  • the present technology further includes methods of shunting fluids through the shunting systems and shunts described herein (e.g., to drain aqueous from the anterior chamber for treating glaucoma).
  • the methods can incorporate any of the techniques described above, including, for example, selectively actuating one or more flow control elements to open and/or close one or more ports (e.g. inflow ports) on a shunt to achieve a target resistance and/or flow.
  • the methods may also include selectively actuating one or more flow control elements to open and/or close one or more ports until a target intraocular pressure is attained.
  • the ports can all be simultaneously unblocked to provide the lowest resistance and highest flow for a given pressure. This may be done in a healthcare provider's office to quickly reduce intraocular pressure. Once a target intraocular pressure is achieved, some or all of the ports can be closed to provide a flow and resistance more suitable for chronic therapy.
  • adjustable shunts such as those provided herein may be able to safely provide higher flow and lower resistance than conventional static (e.g., non-adjustable) shunts.
  • conventional static shunts generally do not provide high flow or low resistance in order to avoid inducing hypotony.
  • the shunts of the present technology can provide high flow and low resistance (e.g., by opening all the ports) that, if left unchanged for a prolonged period, could lead to hypotony.
  • a healthcare provider can adjust the shunt to lower flow and increase resistance.
  • One expected advantage of this is that a healthcare provider can more quickly reduce intraocular pressure in the patient.
  • a system for draining fluid comprising:
  • the drainage element has a first channel fluidly coupled to the first port, a second channel fluidly coupled to the second port, and a third channel fluidly coupled to the third port.
  • first channel has a first cross sectional area
  • second channel has a second cross sectional area greater than the first cross sectional area
  • third channel has a third cross sectional area greater than the second cross sectional area
  • a system for draining fluid comprising:
  • the drainage element includes (i) a first lumen extending between the first inflow port and the second end region, and (ii) a second lumen extending between the second inflow port and the second end region, and wherein the first lumen is configured to provide a different resistance to fluid flow than the second lumen.
  • the drainage element further comprises a fourth inflow port, and wherein when the fourth inflow port is unblocked and the first, second, and third inflow ports are blocked, the system is configured to provide a fourth relative drainage rate through the drainage rate, and wherein a ratio between the first, second, third, and fourth relative drainage rates is about 1:2:4:8.
  • An adjustable shunt comprising:
  • first drainage rate, the second drainage rate, and the third drainage rate are predetermined relative drainage rates, and wherein the first drainage rate is about X, the second drainage rate is about 2X, and the third drainage rate is about 4X.
  • the adjustable shunt of example 34 wherein, when more than one inflow port is open, the shunt is configured to provide a fourth relative drainage rate that is different than the first drainage rate, the second drainage rate, and the third drainage rate.
  • a method of treating glaucoma comprising:
  • actuating at least one of the individually actuatable flow control elements comprises applying energy to at least one of the individually actuatable flow control elements.
  • An adjustable shunt comprising:
  • the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.”
  • the terms “connected,” “coupled,” or any variant thereof means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof.
  • the words “herein,” “above,” “below,” and words of similar import when used in this application, shall refer to this application as a whole and not to any particular portions of this application.

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US11596550B2 (en) 2020-04-16 2023-03-07 Shifamed Holdings, Llc Adjustable glaucoma treatment devices and associated systems and methods
US11737920B2 (en) 2020-02-18 2023-08-29 Shifamed Holdings, Llc Adjustable flow glaucoma shunts having non-linearly arranged flow control elements, and associated systems and methods
US11766355B2 (en) 2020-03-19 2023-09-26 Shifamed Holdings, Llc Intraocular shunts with low-profile actuation elements and associated systems and methods
US11865283B2 (en) 2021-01-22 2024-01-09 Shifamed Holdings, Llc Adjustable shunting systems with plate assemblies, and associated systems and methods

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JP2022552284A (ja) 2019-10-10 2022-12-15 シファメド・ホールディングス・エルエルシー 流量調整可能な緑内障用シャントならびに関連システム及び方法
AU2021209698A1 (en) 2020-01-23 2022-08-04 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and associated systems and methods
AU2021219845A1 (en) 2020-02-14 2022-09-01 Shifamed Holdings, Llc Shunting systems with rotation-based flow control assemblies, and associated systems and methods
WO2023107486A1 (fr) * 2021-12-06 2023-06-15 Shifamed Holdings, Llc Systèmes de dérivation réglables, et systèmes, dispositifs et procédés associés
WO2024030949A1 (fr) * 2022-08-03 2024-02-08 Shifamed Holdings, Llc Systèmes de dérivation réglables comprenant des ensembles d'actionnement, et dispositifs et procédés associés
CN115796082B (zh) * 2023-01-13 2023-06-06 张家港市欧凯医疗器械有限公司 一种双j型导管内径引流数据分析方法及系统

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US20220142818A1 (en) 2022-05-12
CN115379818A (zh) 2022-11-22
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